A Randomized, Double-blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination with Azacitidine Versus Azacitidine in Treatment Naïve Subjects with Acute Myeloid Leukemia who are Ineligible for Standard Induction Therapy, Incorporating Extension Period - Continued Access for Venetoclax. (VIALE-A)
This study, called VIALE-A, is for adults with a type of blood cancer named Acute Myeloid Leukaemia (AML). It's designed for patients who are not suitable for the usual strong initial chemotherapy treatments. The study is comparing a new drug called venetoclax, given alongside an existing medicine called azacitidine, against azacitidine alone. Researchers want to find out if combining venetoclax with azacitidine helps more patients achieve a complete remission – meaning the cancer is no longer detectable – or significantly improves how long people live. They're also looking at how patients feel during treatment, including their energy levels and overall quality of life. This is a Phase 3 study, meaning it’s a large trial to confirm the benefits of the new treatment.
At a glance
What is this study about?
This study, known as VIALE-A, is investigating a new way to treat a type of blood cancer called Acute Myeloid Leukaemia (AML). AML is a cancer that affects the blood and bone marrow, which is the spongy tissue inside your bones where blood cells are made. Normally, this cancer is treated with strong chemotherapy, but some people are too unwell or have other health problems that make this treatment too risky for them.
For these patients, researchers are looking at a combination of two medicines: venetoclax and azacitidine. Azacitidine is a commonly used treatment, and venetoclax is a newer drug. The main goal of the study is to see if giving venetoclax together with azacitidine is more effective than azacitidine alone. They want to know if it helps more people achieve what's called a 'complete remission' (when signs of the cancer disappear) or 'complete remission with incomplete marrow recovery' (when the bone marrow isn't fully back to normal but the cancer is gone). They also want to see if this combination helps people live longer.
Beyond simply fighting the cancer, the study is also very interested in how people feel while on treatment. They will be checking things like how tired people get and their overall quality of life. This is important because treatment shouldn't just extend life, but also help people feel as good as possible. This is a 'Phase 3' study, which means it’s a big, final stage trial to confirm if the new treatment is safe and effective enough to be widely used.
Key takeaways
- This study is for adults with AML who can't have strong chemotherapy.
- It compares a new drug combination (venetoclax + azacitidine) with an existing treatment (azacitidine).
- The main goals are to see if the new combination can clear the cancer or help people live longer.
- Researchers will also track how patients feel and their quality of life.
- This is a large, advanced-stage study to confirm treatment benefits.
Who may be eligible?
This study is open to adults aged 18 or older. There is no upper age limit, meaning older adults can also take part. Both men and women can participate in the study.
The main group of people this study is for are those who have Acute Myeloid Leukaemia (AML) but cannot have the usual strong chemotherapy that is often given for this type of cancer. This might be because of their age, other health conditions, or how well their body is generally doing.
Important note: The study is looking for people who haven't had previous treatment for AML before joining this trial (they are 'treatment-naïve'). Your doctor would need to check if you meet all the specific health requirements to ensure the study is safe and appropriate for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 or older?
- Have you been diagnosed with Acute Myeloid Leukaemia (AML)?
- Have you been told you are not suitable for standard strong initial chemotherapy?
- Have you not received any previous treatment specifically for your AML?
What does participation involve?
If you decide to take part in this study, you would be assigned to receive either the new combination treatment (venetoclax plus azacitidine) or azacitidine alone. You wouldn't know which treatment group you are in, and neither would your doctors, to ensure the results are as fair as possible. These medicines are typically given in cycles, meaning you'll have periods of treatment followed by breaks.
You would have regular visits to the clinic for medical check-ups, blood tests, and to assess how you are feeling and if the treatment is working. These visits might involve physical examinations and discussions about any side effects you might be experiencing. You'll also be asked to fill out questionnaires about your quality of life and energy levels.
The total duration of your participation could vary. You would continue treatment for as long as it is benefiting you and you are tolerating it well. After the main treatment period, there will be a follow-up period to continue monitoring your health and the long-term effects of the treatment. You always have the right to withdraw from the study at any time.
Potential risks and benefits
Locations (6)
- —UnverifiedFinland
- —UnverifiedCzechia
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedBelgium
Common questions
What is Acute Myeloid Leukaemia (AML)?
AML is a cancer that starts in the bone marrow (the soft, inner part of certain bones where new blood cells are made), causing too many abnormal white blood cells to be produced.
What does 'treatment-naïve' mean?
It means you haven't received any previous treatment specifically for your AML before joining this study. You are new to treatment.
What is a 'Phase 3' study?
A Phase 3 study is a large clinical trial designed to compare a new treatment with an existing one. It helps to confirm if the new treatment is safe and effective before it's made widely available.
Will I know which treatment I'm getting?
No, this is a 'blinded' study. Neither you nor your doctor will know if you're receiving venetoclax plus azacitidine or azacitidine alone. This helps make the study results fair.
What happens if the treatment doesn't work for me?
Your doctors will regularly check if the treatment is helping. If it's not working or you experience severe side effects, they would discuss other options for your care with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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